US20110295283A1 - Soft tissue repair prosthesis, expandable device, and method of soft tissue repair - Google Patents

Soft tissue repair prosthesis, expandable device, and method of soft tissue repair Download PDF

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Publication number
US20110295283A1
US20110295283A1 US13/130,625 US200913130625A US2011295283A1 US 20110295283 A1 US20110295283 A1 US 20110295283A1 US 200913130625 A US200913130625 A US 200913130625A US 2011295283 A1 US2011295283 A1 US 2011295283A1
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United States
Prior art keywords
prosthesis
expandable device
soft tissue
tissue repair
hernia
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
US13/130,625
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English (en)
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US9504548B2 (en
Inventor
Roger E. Darois
John Peter Groetelaars
Michael F. Jacene
Anthony Colesanti
Michael J. Lee
Richard V. Longo
Tara Smith
James M. Brann
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CR Bard Inc
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CR Bard Inc
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Publication date
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Priority to US13/130,625 priority Critical patent/US20110295283A1/en
Assigned to C. R. BARD, INC. reassignment C. R. BARD, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: COLESANTI, ANTHONY, JACENE, MICHAEL F., BRANN, JAMES M., LONGO, RICHARD V., SMITH, TARA, DAROIS, ROGER E., GROETELAARS, JOHN PETER, LEE, MICHAEL J.
Publication of US20110295283A1 publication Critical patent/US20110295283A1/en
Granted legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
    • A61F2002/0072—Delivery tools therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having an inflatable pocket filled with fluid, e.g. liquid or gas

Definitions

  • the present invention is directed to a soft tissue repair prosthesis, an expandable device, and to a method of soft tissue repair.
  • One technique for repairing a soft tissue defect involves inserting an implantable prosthesis, such as a mesh patch or plug, into an intra-abdominal space, positioning the prosthesis relative to the wall defect, and then, if desired, securing the prosthesis with tacks, sutures, and/or adhesives.
  • an implantable prosthesis such as a mesh patch or plug
  • the prosthesis may be rolled up, folded or otherwise collapsed into a reduced profile and then inserted through a small incision or a trocar and into the intra-abdominal space. The prosthesis is then unfurled and positioned relative to the defect.
  • a hernia repair device which includes a soft tissue repair prosthesis and at least one loop extending from the prosthesis.
  • the at least one loop has a predetermined size configured to receive a portion of an expandable device to removably connect the prosthesis with the expandable device.
  • a hernia repair device which includes a soft tissue repair prosthesis having at least one slit therethrough, where the at least one slit has a predetermined size configured to receive a portion of an expandable device to removably connect the prosthesis with the expandable device.
  • a hernia repair device which includes a soft tissue repair prosthesis having a first side and a second side, and at least one attachment component coupled to the prosthesis and extending outwardly from the first side of the prosthesis.
  • the attachment component is configured to receive a portion of an expandable device to removably connect the prosthesis with the expandable device.
  • the hernia repair device further includes a tether coupled to the prosthesis and extending outwardly from the second side of the prosthesis, where manipulation of the tether allows hoisting, locating and/or positioning of the soft tissue repair prosthesis.
  • a hernia repair device which includes an expandable device configured to be removably connected with a soft tissue repair prosthesis, where the expandable device includes indicia for referencing a predetermined location for positioning an edge of a hernia defect relative to the prosthesis such that the prosthesis overlaps the edge of the defect a predetermined distance.
  • a method of delivering a soft tissue repair prosthesis includes removably connecting at least one loop of a soft tissue repair prosthesis with a portion of an expandable device, and expanding the expandable device.
  • a method of delivering a soft tissue repair prosthesis includes removably connecting at least one slit of a soft tissue repair prosthesis with an expandable device by inserting a portion of the expandable device into the at least one slit, and expanding the expandable device.
  • a method of repairing a hernia defect includes removably connecting at least one attachment component coupled to a first side of a soft tissue repair prosthesis with an expandable device to removably connect the soft tissue repair prosthesis with the expandable device, inserting the prosthesis and the expandable device into an abdominal space, expanding the expandable device, and manipulating a tether coupled to a second side of the soft tissue repair prosthesis to hoist, locate or position the soft tissue repair prosthesis.
  • a method of repairing a hernia defect includes inserting a soft tissue repair prosthesis and an expandable device into an abdominal space where the expandable device is removably connected to the soft tissue repair prosthesis and wherein the expandable device includes indicia referencing a predetermined location, expanding the expandable device, and positioning the prosthesis around a hernia defect in an abdominal wall by positioning an edge of the hernia defect at the indicia referencing the predetermined location such that the prosthesis overlaps the edge of the defect a predetermined distance.
  • FIG. 1 is a perspective view of an expandable device and soft tissue repair prosthesis according to one embodiment of the present invention
  • FIG. 2 is a perspective view of the soft tissue repair prosthesis shown in FIG. 1 ;
  • FIG. 3 is a top view of the expandable device shown in FIG. 1 ;
  • FIG. 4 is a perspective view of an expandable device and soft tissue repair prosthesis according to another embodiment of the present invention.
  • FIG. 5 is a perspective view of the soft tissue repair prosthesis shown in FIG. 4 ;
  • FIG. 6 is a top view of the expandable device shown in FIG. 4 ;
  • FIG. 7 is a top view of an expandable device according to another embodiment.
  • FIG. 8 is a detailed view of a portion of an expandable device according to one embodiment
  • FIG. 9 is a top view of an expandable device according to another embodiment.
  • FIG. 10 is a bottom view of an expandable device and soft tissue repair prosthesis according to one embodiment of the present invention.
  • FIG. 11 is a perspective view of an expandable device and prosthesis according to yet another embodiment of the present invention.
  • FIG. 12 is a top view of an expandable device according to one embodiment.
  • FIG. 13 is a partial view of an expandable device and soft tissue repair prosthesis according to another embodiment.
  • aspects of the present invention are directed to a soft tissue repair prosthesis, such as a patch, plug, or patch and plug combination, for repairing, augmenting or reconstructing a muscle or tissue wall, such as a chest wall or abdominal wall, and that has particular application for repairing a hernia defect and for reconstruction of the chest wall.
  • An expandable device may be provided for delivering, locating and/or positioning the soft tissue repair prosthesis at the surgical site.
  • the soft tissue repair prosthesis may be carried by, tethered to, or otherwise operatively connected with the expandable device, such that manipulation of the expandable device will effect the shape, location and/or positioning of the soft tissue repair prosthesis.
  • the expandable device may have a reduced configuration suitable for introduction to the surgical site and an expanded configuration for deploying, locating and/or positioning the soft tissue repair prosthesis. Expansion of the expandable device, when carrying or otherwise integrated with the soft tissue repair prosthesis, may cause the soft tissue repair prosthesis to transform from a reduced delivery profile to an enlarged shape suitable for the desired procedure, such as extending over, under, or filling a hernia defect.
  • the expandable device may be in the form of a balloon or other inflatable bladder, or other construction suitable for delivery in a reduced profile and expansion to a larger size.
  • the soft tissue repair prosthesis may be mounted to, or otherwise integrated with, the expandable device, and then the combined components may be reduced in size, such as by rolling, folding, or otherwise collapsing, and then inserting through a trocar or small incision into the abdominal cavity or other surgical site.
  • Expansion of the expandable device such as by inflation where the expandable device is in the form of a balloon, will in turn cause the soft tissue repair prosthesis to move into an expanded configuration suitable for the intended procedure.
  • inflation of the balloon will cause the mesh sheet to unroll or otherwise expand into an enlarged shape which can then be positioned relative to the defect.
  • aspects of the present invention are directed to arrangements for operatively connecting an expandable device with a soft tissue repair prosthesis.
  • the expandable device and soft tissue repair prosthesis are detachably connected.
  • one or more loops or other attachment features may releasably connect the expandable device and soft tissue repair prosthesis.
  • the loops may loosely connect the components together in the reduced profile, or the loops may not contribute to attachment of the expandable device and soft tissue repair prosthesis until one or both of the expandable device and soft tissue repair prosthesis are in an expanded configuration.
  • aspects of the present invention are directed to various approaches to hoist, locate, center or position the prosthesis relative to the defect, and yet further aspects of the present invention are directed to indicia on the expandable device for positioning the prosthesis relative to the hernia defect.
  • the expandable device has a plurality of outwardly extending arms 12 .
  • the expandable device 10 is shaped like a starfish.
  • the expandable device may be shaped differently in other embodiments.
  • the expandable device may be circular, rectangular, lattice shaped or irregular shaped as the invention is not so limited.
  • the expandable device 10 may have an open center portion 14 .
  • the open portion may minimize the size or bulk of the expandable device when the expandable device 10 is rolled or folded into a reduced profile configuration. This may assist with the insertion of the expandable device 10 , such as through a small incision or a trocar.
  • the expandable device is asymmetric about the axis which the expandable device is folded or rolled. In this respect, overlap of the arms 12 of the expandable device 10 is minimized if not avoided, reducing the overall profile of the collapsed expandable device. Smaller profiles may be desired to facilitate or permit use with narrow trocar diameters and small incisions.
  • an inflation port 20 is positioned on the end of a radially extending arm 12 of the expandable device.
  • the inflation port 20 may extend from a different location of the expandable device, and may for example extend from a center portion of the expandable device 10 .
  • An inflation tube 22 runs to the inflation port 20 .
  • the inflation tube 22 may be detachably secured to the inflation port 20 so that the tube 22 can be removed after inflation.
  • the inflation tube 22 may pass through a trocar (not shown) to outside of the patient for connection to an inflation source, such as a syringe.
  • the invention is not limited to a particular inflation medium.
  • a gas such as air
  • a liquid such as saline.
  • suitable mediums will be apparent to one of skill in the art.
  • the expandable device is not limited to inflatable configurations and other arrangements that have a slender configuration suitable for delivery and an expanded configuration for deployment, locating and/or positioning of the soft tissue repair prosthesis are contemplated.
  • the expandable device 10 may be removably connected with the soft tissue repair prosthesis 30 by one or more attachment components, including, but not limited to sutures, adhesives, or mechanical fasteners including hook and loop fasteners, rivets, and the like.
  • an adhesive may be used to detachably connect the prosthesis 30 and the expandable device 10 . It is contemplated that a sugar adhesive may be used that dissolves when wetted.
  • the attachment component is at least one loop 40 extending from the prosthesis 30 .
  • the loop may have a variable size or, instead, have a predetermined size compatible for securing with a portion of the expandable device.
  • the loop may be sized to connectably receive a portion of the expandable device when it reaches an expanded configuration.
  • the loops may define an opening that closely fits around the connecting portion of the expandable device only in the expanded configuration, or the loops may closely fit around the connecting portion in both the reduced profile and expanded configuration.
  • the loops may be compliant or non-compliant, and the loop opening may expand in response to expansion of the expandable device. For example, as illustrated in FIGS.
  • a plurality of loops 40 may extend from the soft tissue repair prosthesis 30 and one or more arms 12 of the expandable device 10 may extend into the loops 40 , removably connecting the expandable device with the soft tissue repair prosthesis.
  • the loops may be similar to a belt loop and portions of the expandable device may be configured to fit in the loops.
  • These loops may be formed of a resorbable or a non-resorbable material, as the invention is not limited in this respect.
  • the loops 40 may be secured to the prosthesis as shown in FIG. 2 and thereafter secured to the expandable device.
  • the loops 40 may initially be wrapped around the expandable device and thereafter secured to the prosthesis as the invention is not so limited.
  • the one or more loops might be formed on the expandable device with complementary attachment arrangements being provided on the soft tissue repair prosthesis.
  • the size of the loop 40 is based upon the size of the portion of the expandable device 10 that would be received within the loop 40 .
  • the loop has a diameter of approximately 2 cm to approximately 10 cm. In another embodiment, the loop has a diameter of at least approximately 5 cm.
  • the loop 40 may be sized to be slightly larger than the expandable device to accommodate the expandable device 10 within the loop 40 .
  • the loops 40 are spaced apart and discretely formed. As illustrated, each loop may terminate in a knot or weld that prevents the loop 40 from detaching from the prosthesis 30 . As discussed in greater detail below, in another embodiment, the loops 40 are part of an integral structure, such as a running suture.
  • the loops 40 may be formed from a variety of materials, as the invention is not limited in this respect.
  • the loops 40 are formed from suture material, such as but not limited to polyglycolic acid (PGA), or Vicryl® which is a polyglactin absorbable suture material.
  • the loops 40 are formed from soft tissue repair fabric, such as, but not limited to expanded polytetrafluorethylene (ePTFE).
  • the loops may be configured to encourage tissue infiltration, to resist tissue infiltration, or to provide localized and differing tissue infiltration properties.
  • the loops may be formed of a barrier material, include a barrier material, and/or include a coating or surface treatment that discourages, or encourages, tissue ingrowth.
  • the expandable device 10 may also be formed from a variety of materials, as the invention is not limited in this respect.
  • the expandable device is formed of polyurethane, and may, for example, be formed of nylon coated polyurethane.
  • the expandable device 10 may be formed of two layers of nylon coated polyurethane that together form a chamber for the introduction of air.
  • a tether 50 may be coupled to the soft tissue repair prosthesis 30 to assist in hoisting, locating and/or positioning the soft tissue repair prosthesis, and the expandable device if it still is connected therewith.
  • the soft tissue repair prosthesis has a first side and a second side where at least one attachment component (such as the loops 40 ) extend from the first side of the prosthesis and the tether 50 extends from the second side of the prosthesis.
  • the tether 50 may be formed from a suture, soft tissue repair fabric, or other material as should be apparent to one of skill in the art.
  • the tether may be resorbable or permanent.
  • the tether may be singular or include a plurality of tether segments, for example the tether 50 may include a plurality of sutures or strips that are spaced about the prosthesis.
  • the tether 50 may be secured approximately at the center of the prosthesis 30 , or surrounding the center of the prosthesis, such that the center of the prosthesis can more readily be aligned with the center of the hernia defect.
  • the invention is not limited to a tether that focuses forces at or about the center of the soft tissue repair prosthesis.
  • a suture-grasping device may be provided to grasp the tether and hoist the prosthesis 30 towards the defect and/or to position the soft tissue repair prosthesis against the abdominal wall.
  • the tether 50 includes a loop 52 adapted for grasping and manipulation by a surgical instrument or the physician's hands.
  • the loops 40 may be left in place or, instead, removed.
  • an instrument may be employed to cut the loops. It may be desirable to separate the soft tissue repair prosthesis from the expandable device prior to removing the loops.
  • the soft tissue repair prosthesis may be separable from an expanded expandable device and, in certain embodiments, it may facilitate separation by at least partially reducing the size of the expandable device (e.g., such as by at least partially deflating where the expandable device is a balloon). As mentioned above, it is also contemplated that the loops 40 are resorbable.
  • one or more of the loops 40 may be used as transfacial sutures to secure the prosthesis 30 around the defect.
  • the expandable device 10 may be detached from the prosthesis 30 without cutting and/or removing some or all of the loops 40 .
  • Such loops 40 themselves, or cut into strands, may then be used to secure the prosthesis.
  • sutures, distinct from the tether may be pre-attached to the soft tissue repair prosthesis and used to secure the implant relative to the defect.
  • a method of repairing a hernia defect in accordance with the present invention includes one or more of the steps of: detachably securing an expandable device to a prosthesis, rolling or folding the prosthesis and detachably secured expandable device into a slender configuration, inserting the prosthesis and expandable device into the intra-intra-abdominal space, inflating the expandable device to unfurl the mesh, pulling on a tether coupled to the prosthesis to hoist the prosthesis up against the abdominal wall, fixating the prosthesis against the abdominal wall, detaching the expandable device from the prosthesis, and removing the expandable device from the intra-intra-abdominal space.
  • One method of delivering a soft tissue repair prosthesis includes removably connecting at least one loop of a soft tissue repair prosthesis with a portion of an expandable device, and expanding the expandable device.
  • the method may also include inserting the prosthesis and the expandable device into an abdominal space, positioning the prosthesis around a hernia defect in an abdominal wall, securing the prosthesis to the abdominal wall, and detaching the prosthesis and the expandable device.
  • Another method of repairing a hernia defect includes removably connecting at least one attachment component coupled to a first side of a soft tissue repair prosthesis with an expandable device to removably connect the soft tissue repair prosthesis with the expandable device, inserting the prosthesis and the expandable device into an abdominal space, expanding the expandable device, and manipulating a tether coupled to a second side of the soft tissue repair prosthesis to hoist, locate or position the soft tissue repair prosthesis.
  • the method may further include securing the prosthesis to the abdominal wall, and detaching the prosthesis and the at least one attachment component.
  • the prosthesis 30 may be formed of a porous material, such as a knit, woven or non-woven fabric, or may be composed of a solid, substantially non-porous, or micro-porous material.
  • the prosthesis may be formed of one or more layers of the same or dissimilar material.
  • the prosthesis may be formed with portions that are tissue infiltratable and other portions that are non-tissue infiltratable, providing selected areas of the repair device with different tissue ingrowth and adhesion resistant properties.
  • the prosthesis may be formed of permanent material, resorbable material, or a combination of permanent and resorbable materials. It should be appreciated that the prosthesis may be formed of any biologically compatible material, synthetic or natural, suitable for repairing a tissue or muscle wall defect as would be apparent to one of skill in the art.
  • the prosthesis may be formed into a patch, plug or combination patch and plug.
  • the prosthesis 30 is formed from a mesh fabric, such as a sheet of knitted polypropylene monofilament mesh fabric.
  • the sheet may have a thickness of approximately 0.014 inches and may be knitted from polypropylene monofilament having a diameter of approximately 0.0042 inches.
  • the polypropylene mesh promotes rapid tissue or muscle ingrowth into and around the mesh structure.
  • other surgical materials which are suitable for tissue or muscle reinforcement and defect correction may be utilized including BARD MESH (available from C.R. Bard, Inc.), SOFT TISSUE PATCH (microporous ePTFE—available from W.L.
  • the fabric may be formed from multifilament yarns and that any suitable method, such as knitting, weaving, braiding, molding and the like, may be employed to form the mesh material.
  • any suitable method such as knitting, weaving, braiding, molding and the like, may be employed to form the mesh material.
  • the soft tissue repair prosthesis when in the form of a sheet, it may be configured in many shapes, including, but not limited to flat, concave, and convex, and may, for example, be in the form of a square, rectangle, circle, or ellipse.
  • the expandable device 60 is lattice shaped and has a plurality of outwardly extending arms 62 .
  • the expandable device 60 includes an open center portion 64 which, as mentioned above, may minimize the size or bulk of the expandable device 60 when the expandable device is rolled or folded into a reduced profile configuration.
  • an inflation port 20 allows the expandable device to be inflated or otherwise expanded into a larger profile configuration.
  • the inflation port 20 is positioned on an end of an outwardly extending arm 62 of the expandable device.
  • the expandable device 62 may be inflated with a gas, such as air, or the expandable device may be filled with a liquid, such as saline, to reach an expanded profile.
  • a gas such as air
  • a liquid such as saline
  • a plurality of loops 70 are secured to the prosthesis 30 and the loops 70 are configured to receive portions of the expandable device 60 , removably connecting the expandable device and the prosthesis.
  • the plurality of loops 70 may be part of a continuum, or integrated structure, such as a running suture, such that a plurality of loops 70 are formed with the same length of suture. Similar to the embodiment shown in FIG. 1 , the loops 70 extend through the prosthesis and one or more arms 62 of the expandable device 60 extend into the loops 70 to secure the expandable device with the prosthesis. It should be appreciated that in one embodiment, the size of the loops 70 may be adjustable.
  • the size of the loops 70 may be adjustable by pulling the loop 70 through the prosthesis.
  • the prosthesis 30 may also include a tether 50 , which further may be provided with a loop 52 on one end, to assist in hoisting, locating and/or positioning the soft tissue repair prosthesis.
  • the loops 70 may be cut and removed from the expandable device/prosthesis interface. It is also contemplated that the loops 70 may not need to be cut to detach the expandable device from the prosthesis, as the loops 40 may be configured such that the arm 62 of the expandable device may slide out of the loop and/or the loops may be configured to be absorbable within the body.
  • the expandable device 60 is deflated or otherwise transformed into its reduced profile configuration and the expandable device may be withdrawn from the intra-abdominal space through a trocar.
  • an inflation tube 22 may be detachably secured to the inflation port 20 and the inflation tube 22 may pass through a trocar (not shown) to enable inflation of the expandable device from outside of the body. It is also contemplated that a one-way inflation valve could be used so that once the expandable device is inflated, the inflation tube 22 may be removed from the trocar to free up the trocar for other instruments. The inflation tube 22 may either be detached from the inflation port 20 and removed from the body, or the inflation tube may be tucked back into the intra-abdominal space and may be removed with the expandable device.
  • the expandable device may be inflated through an inflation port positioned on the underside of the expandable device.
  • the inflation port may be grasped to both inflate and manipulate the expandable device.
  • FIGS. 7 and 8 illustrate a feature for facilitating connection of one or more loops with the expandable device.
  • At least one indentation 84 is provided on the expandable device which receives a loop 40 , 70 .
  • the indentations 84 are reduced dimensioned regions of the expandable device and the indentations may be shaped to prevent the loop 40 , 70 from undesirably sliding off and detaching from the expandable device 80 .
  • the indentations 84 are circumferential, such that they extend substantially around the arm of the expandable device, although an interrupted or partially circumferential indentation also is contemplated.
  • the indentation may be formed by the region between two spaced apart protrusions on the expandable device.
  • the loop 40 , 70 may be cut away from the indentation 84 , or the loop 40 , 70 may be slid over the indentation 84 to detach the expandable device 80 from the prosthesis 30 . It should be appreciated that once the expandable device is deflated or otherwise transformed into its reduced profile configuration, it may be easier to dislodge the loop from the indentation 84 in the expandable device 80 .
  • a tether 50 may be secured to the prosthesis to assist in hoisting the prosthesis and the expandable device up to the defect.
  • the inflation tube 22 may be used to hoist the prosthesis and the expandable device up to the defect.
  • the inflation tube 22 may be secured to an inflation port 20 at approximately the center of the prosthesis 30 and the inflation tube 22 may pass through the prosthesis 30 .
  • a suture-grasping device (not shown) may be passed through the skin in the middle of the defect.
  • the inflation tube 22 may be pulled upward with the grasping device to hoist the prosthesis 30 into position against the abdominal wall. As shown, in one embodiment, the inflation tube 22 is secured to the center of the prosthesis 30 such that the prosthesis 30 can more readily be aligned with the center of the hernia defect. Once the prosthesis 30 is pulled up and positioned relative to the defect, the prosthesis 30 may be fixated to the margins of the defect using sutures, fasteners, adhesives or the like in accordance with any of the techniques known to one of ordinary skill in the art. As shown in the embodiment of FIG. 9 , the inflation tube 22 may extend through the prosthesis, and may for example, extend through the mesh of the prosthesis. After inflation, the inflation tube 22 may be disconnected from the inflation port 20 such that the tube 22 can be removed through the defect. Thereafter, the expandable device 90 can be detached from the prosthesis and deflated, such that the expandable device can be removed from the body.
  • FIG. 10 illustrates a bottom view of an expandable device 100 and a prosthesis 30 positioned to cover a defect 110 (shown in dashed lines as it may not be visible through the prosthesis 30 ).
  • the expandable device 100 has indicia 102 , which, in this particular embodiment is similar to a ruler and may assist in centering the prosthesis 30 relative to the defect 110 and/or measuring the amount that the prosthesis overlaps the defect.
  • the indicia 102 may include numeric indicia.
  • the indicia 102 may be used to measure the amount of overlap of the prosthesis in one or more directions. The position of the prosthesis 30 may then be adjusted accordingly. For example, the indicia 102 may be used for referencing a predetermined location for positioning an edge of a hernia defect relative to the prosthesis such that the prosthesis overlaps the edge of the defect a predetermined distance.
  • FIG. 7 illustrates another embodiment of an expandable device 80 having indicia 102 .
  • the expandable device 100 may further include indicia such as, but not limited to markers, arrows, or other indicia to help to orient the expandable device and prosthesis and/or to indicate selected extraction points on the expandable device where the expandable device should be grasped to remove the expandable device from the body.
  • the indicia may also be used to show the long axis about which the expandable device may be rolled to insert into the body.
  • indicia may be used to indicate the locations of the attachment components.
  • the indicia is visible, and may for example include colored markings.
  • the indicia may only be visible with special imaging tools, and in yet another embodiment, the indicia may be tactile such that the indicia includes a surface that a user can sense by touch.
  • FIG. 13 another embodiment of an expandable device with indicia is illustrated.
  • the expandable device 220 includes a tab 270 which includes indicia 260 .
  • This indicia is for referencing a predetermined location for positioning an edge 250 of a hernia defect (shown in dashed lines) relative to the prosthesis 200 such that the prosthesis 200 overlaps the edge 250 of the defect a predetermined distance “d”.
  • the prosthesis 200 is secured with the expandable device 220 such that the outer perimeter of the prosthesis is approximately 1 cm away from the edge of the tab 270 .
  • the tab 270 includes indicia 260 which includes a plurality of markings that are spaced apart approximately 1 cm.
  • a user is able to use the indicia 260 such that the prosthesis 200 overlaps the edge 250 of the defect a predetermined distance “d” which is equal to 4 cm in the illustrative embodiment.
  • the predetermined distance is between approximately 3 cm-approximately 5 cm. However, it should be appreciated that the predetermined distance may vary based upon the particular defect and prosthesis.
  • One method of repairing a hernia defect includes inserting a soft tissue repair prosthesis and an expandable device into an abdominal space where the expandable device is removably connected to the soft tissue repair prosthesis and where the expandable device includes indicia referencing a predetermined location, expanding the expandable device, and positioning the prosthesis around a hernia defect in an abdominal wall by positioning an edge of the hernia defect at the indicia referencing the predetermined location such that the prosthesis overlaps the edge of the defect a predetermined distance.
  • the prosthesis 130 may include at least one slit 132 having a predetermined size configured to receive a portion of the expandable device 120 to removably connect the prosthesis to the expandable device.
  • the expandable device 120 has a plurality of arms 122 that are configured to slide into a plurality of slits 132 in the prosthesis.
  • the expandable device 120 may be removably connected with the prosthesis 130 when in its reduced or deflated profile configuration, and then, as discussed above, the expandable device may be expanded or inflated once the prosthesis 130 and expandable device are positioned in the body near the defect.
  • the expandable device may be detached from the prosthesis by pulling or sliding the arms 122 of the expandable device 120 out from the slits 132 in the prosthesis 130 .
  • detaching the expandable device 120 from the prosthesis 130 may be more easily facilitated after the expandable device 120 is deflated or otherwise transformed back into its reduced profile configuration.
  • end portions of the expandable device 130 may remain in a reduced profile when other portions of the expandable device are expanded or inflated.
  • the end portions of arms 122 may include non-expandable portions 124 . These non-expandable portions 124 may be passed through the slits 132 in the prosthesis 130 and they may assist in retaining the arms of the expandable device within the slit 132 after the expandable device is expanded or inflated. Also, these non-expandable portions 124 may help to keep the prosthesis 130 lying substantially flush with the defect and the abdominal wall.
  • the size of the slit 132 is based upon the size of the portion of the expandable device 10 that would be received within the slit 132 .
  • the slit has a diameter of approximately 2 cm to approximately 10 cm. In another embodiment, the slit has a diameter of at least approximately 5 cm.
  • the slit 132 may be sized to be slightly larger than the expandable device to accommodate the expandable device 10 within the slit 132 .
  • One method of delivering a soft tissue repair prosthesis includes removably connecting at least one slit of a soft tissue repair prosthesis with an expandable device by inserting a portion of the expandable device into the at least one slit, and expanding the expandable device.
  • the present invention also contemplates other systems for expanding and/or unfurling the prosthesis.
  • inflatable expandable devices either filled with a gas or a liquid
  • other expandable devices that don't rely on inflation are contemplated.
  • an expandable device that includes telescoping portions and/or umbrella-like spokes an expandable device including shape memory material, and an expandable device that resiliently expands into an enlarged configuration.
US13/130,625 2008-11-21 2009-11-20 Soft tissue repair prosthesis, expandable device, and method of soft tissue repair Granted US20110295283A1 (en)

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US13/130,625 US20110295283A1 (en) 2008-11-21 2009-11-20 Soft tissue repair prosthesis, expandable device, and method of soft tissue repair
PCT/US2009/006223 WO2010059234A1 (fr) 2008-11-21 2009-11-20 Prothèse de réparation de tissu mou, dispositif extensible, et procédé de réparation de tissu mou

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EP2358279A4 (fr) 2017-11-15
CA2744206A1 (fr) 2010-05-27
US10548703B2 (en) 2020-02-04
EP2358279B1 (fr) 2020-06-24
US20170100229A1 (en) 2017-04-13
CA2744206C (fr) 2019-05-21
EP2358279A1 (fr) 2011-08-24
WO2010059234A1 (fr) 2010-05-27
ES2813298T3 (es) 2021-03-23
US9504548B2 (en) 2016-11-29

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